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Tulisokibart in Patients with Systemic Sclerosis-Associated Interstitial Lung Disease

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is studying Systemic Sclerosis Associated with Interstitial Lung Disease, a condition in which the immune system causes hardening of the skin and can also lead to scarring in the lungs. The treatment being tested is tulisokibart (also called MK-7240/PRA023), given by vein as an infusion. The purpose of the study is to see how safe this medicine is and whether it may help people with this lung disease. Some participants will receive tulisokibart and others will receive placebo.

The study is planned to last about 50 weeks for each person. During the study, treatment is given at regular times, and health checks are done over the course of the trial to watch for side effects and other changes in health. The study also looks at lung function, which means how well the lungs move air in and out.

The research process

"[\n {\n \"step\": \"study entry and random assignment\",\n \"step_number\": \"1\",\n \"details\": [\n \"After you join the study, you are placed into one of two groups by chance. The study is double blind, which means that neither you nor the study team knows whether you are receiving the study medicine or placebo during the trial. The placebo is 0.9% normal saline, which is a salt water solution that looks like the study medicine but has no active drug.\",\n \"The study medicine is tulisokibart, also referred to in the study title as MK-7240/PRA023. It is given through a vein as an intravenous infusion. The dose is 1000 mg each time it is given.\"\n ]\n },\n {\n \"step\": \"treatment period over 50 weeks\",\n \"step_number\": \"2\",\n \"details\": [\n \"You receive either tulisokibart 1000 mg by intravenous infusion or the placebo. The treatment period lasts for 50 weeks.\",\n \"The study compares tulisokibart with placebo during this time to assess safety, how well the treatment is tolerated, and whether lung function changes over time.\"\n ]\n },\n {\n \"step\": \"study assessments during treatment\",\n \"step_number\": \"3\",\n \"details\": [\n \"During the 50-week study period, you have checks for side effects, including serious side effects, side effects that lead to stopping the study treatment, and laboratory test results that are clearly outside the normal range.\",\n \"Your lung function is measured using FVC, which means forced vital capacity. This is the amount of air you can breathe out after taking a deep breath.\",\n \"At Week 50, the study compares changes from the start of the study in FVC between the two groups.\"\n ]\n },\n {\n \"step\": \"week 50 evaluations\",\n \"step_number\": \"4\",\n \"details\": [\n \"At Week 50, the study also checks lung scans using HRCT QILD-WL. HRCT means high-resolution computed tomography, which is a detailed lung scan. QILD-WL is a study measure used to assess changes in the lungs.\",\n \"At the same time point, the study checks the revised CRISS score, which is a study score used to measure improvement in systemic sclerosis.\",\n \"The study also assesses HAQ-DI, which means health assessment questionnaire-disability index. This measures how much your condition affects daily activities.\",\n \"The study evaluates l-pf patient-reported quality of life, which is information you report about how your condition affects your daily life and well-being.\"\n ]\n }\n]

Who can join the trial?

18 criteria

  • Be an adult aged 18 years or older.
  • Have systemic sclerosis according to the 2013 ACR/EULAR definition. This means the study doctor must confirm the diagnosis using set medical criteria.
  • Have had the first symptom of systemic sclerosis, other than Raynaud symptom (episodes where fingers or toes change color because of reduced blood flow), within the last 5 years before screening.
  • Have diffuse cutaneous scleroderma, meaning skin thickening in areas above the elbows or knees, but not just on the face and neck.
  • Have a total mRSS score between 10 and 35. The mRSS is a skin score used by doctors to measure how much the skin is thickened.
  • Have interstitial lung disease related to systemic sclerosis with fibrotic changes in the lungs, confirmed by a high-resolution CT scan (HRCT, a detailed lung scan), affecting at least 10% of the lungs.
  • Have forced vital capacity (FVC, the amount of air you can breathe out after taking a deep breath) of at least 45% of the expected normal value.
  • Have diffusing capacity of the lung for carbon monoxide (DLCO, a test that shows how well oxygen passes from the lungs into the blood) of at least 45% of the expected normal value, after correcting for hemoglobin, the oxygen-carrying part of blood.
  • Have at least one of the following signs of inflammation or disease activity: C-reactive protein (CRP, a blood test for inflammation) above the normal limit, erythrocyte sedimentation rate (ESR, another blood test for inflammation) above 28 mm/hr, or a positive anti-topoisomerase (anti-Scl-70) antibody test.
  • If using background treatment, meet the required stability rules: take only one of the allowed medicines, such as mycophenolate mofetil up to 3 g/day, methotrexate up to 25 mg/week, or azathioprine up to 150 mg/day, for at least 4 months before randomization and stay on a stable dose for the last 4 weeks before randomization.
  • If using nintedanib, have taken it for at least 6 months and been on a stable dose for at least 4 weeks before randomization, with no improvement in FVC after starting nintedanib.
  • If taking oral corticosteroids (steroid medicines by mouth), be on a stable dose of 10 mg/day or less of prednisone equivalent for at least 2 weeks before randomization. Inhaled and topical corticosteroids are allowed.
  • If female and able to become pregnant, not be pregnant or breastfeeding.
  • If female and able to become pregnant, use an acceptable contraceptive method or practice long-term and consistent abstinence from penile-vaginal sex from at least 4 weeks before the first study dose, during the study, and for at least 14 weeks after the last dose.
  • If female and able to become pregnant, have a negative pregnancy test before starting the study.
  • Have medical history, menstrual history, and recent sexual activity reviewed by the study doctor to lower the chance of an early pregnancy that was not yet detected.
  • Be able to give written informed consent, which means signing a form showing you understand the study and agree to take part.
  • Be able to understand and follow the study rules and requirements.

Who cannot join the trial?

11 criteria

  • Any history of cancer within the last 5 years, except for non-melanoma skin cancer that has been fully removed, or cervical carcinoma in situ / localized cervical cancer that was treated with surgery and fully removed.
  • Any non-melanoma skin cancer that is still present and has not been removed before joining the study.
  • Active tuberculosis (TB), which is a serious infection that usually affects the lungs, or meeting any study rules that exclude people with TB risk.
  • Long-lasting or repeated infections, such as chronic pyelonephritis (ongoing kidney infection), osteomyelitis (bone infection), or bronchiectasis (permanent widening of the airways that can lead to repeated lung infections).
  • Any active infection, except for fungal infection of the nail bed, including infections that need IV treatment, which means medicine given into a vein, or IM treatment, which means medicine given into a muscle, within 4 weeks before randomization.
  • Any active infection that needed oral antibiotics, which are medicines taken by mouth, within 2 weeks before randomization.
  • Known infection with HBV (hepatitis B virus, a virus that infects the liver).
  • Known infection with HCV (hepatitis C virus, a virus that infects the liver).
  • Known infection with HIV (human immunodeficiency virus, a virus that weakens the immune system).
  • Positive HBsAg test, which means there is evidence of current hepatitis B infection.
  • Negative HBsAg but positive HBcAb with HBV-DNA at or above the allowed level. HBcAb is a blood test that can show past hepatitis B infection, and HBV-DNA means the amount of hepatitis B virus genetic material in the blood.
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Investigated drugs

tulisokibart is the study medicine being tested in this trial. It is given through a vein as an infusion. The goal is to see whether it is safe and well tolerated, and whether it can help slow down the loss of lung function in people with systemic sclerosis-associated interstitial lung disease.

What is already known about the treatment

Tulisokibart - Tulisokibart is given as a concentrate for solution for infusion, which means it is prepared and given by vein in a clinic or hospital. It is still an investigational medicine and is being studied in medical literature for immune-related diseases, including conditions where the body’s defense system causes inflammation and tissue damage. Its main use in research is for systemic sclerosis with interstitial lung disease, a condition that can cause scarring and breathing problems. It is a biologic medicine and a monoclonal antibody that is designed to block a specific immune signal involved in inflammation, helping to reduce harmful immune activity at the molecular level.

Investigated diseases

Systemic sclerosis associated with interstitial lung disease - A form of systemic sclerosis in which the lungs become involved with scarring and inflammation in the tissue around the air sacs. It usually begins as a gradual worsening of skin-related sclerosis along with slow damage to the lungs. Over time, the lung tissue becomes stiffer, which can reduce how well the lungs expand and exchange air. The condition may progress at different speeds, with periods of relative stability and periods of worsening.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509743-27-00Protocol codePR200-104_MK-7240-00Estimated enrolment152 patientsSponsorPrometheus Biosciences Inc.

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